FDA Inspection
Compass Health Brands Corp.Compass Health Brands Corp. – FDA Inspection, Oct 12, 2016
Record Details
This FDA Inspection record concerns Compass Health Brands Corp., with an inspection on October 12, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Matthew R. Mcnew (Issuing Officer)
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ID · 317940ce-a862-489d-af0d-0ac309ef7260
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 988940
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
13- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(g)Design validation - production units
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Other FDA inspections of Compass Health Brands Corp.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 16, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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